Yesterday, 11 Democratic senators sent a letter to Shaun Donovan, the director of White House Office of Management and Budget (OMB) pushing for a quick decision from the agency regarding its review process of the proposed regulations of tobacco products by the U.S. Food & Drug Administration (FDA).
Sen. Dick Durbin, D-Ill., along with Richard Blumenthal, D-Conn.; Barbara Boxer, D-Calif.; Sherrod Brown, D-Ohio; Dianne Feinstein, D-Calif.; Edward J. Markey, D-Mass.; Jeff Merkley, D-Ore.; Patty Murray, D-Wash.; Jack Reed, D-R.I.; Charles E. Schumer, D-N.Y., and Elizabeth Warren, D-Mass. asked OMB for a quicker decision on the matter and to not move a grandfather date. The letter largely focuses on e-cigarettes, but does mention cigars when it comes to tobacco products with flavors.
(For more information about the proposed deeming regulations moving to OMB, click here.)
Earlier this week, it became known that OMB had received the finalized proposal from FDA regarding the potential regulation of cigars, e-cigarettes and vapor products, pipes and hookah tobacco. This now means the proposed regulations are in one of their final steps; OMB will review FDA’s finalized proposal and potentially make changes. Once this process is complete, the new rules can be announced in the Federal Register and become law 30 days after that.
Officially, OMB’s Office of Information and Regulatory Affairs (OIRA) has 90 days to review FDA’s proposal, this time frame comes from Executive Order 13563, a directive from President Obama in 2011 in order to make executive agencies move quicker. That being said, the 90-day period isn’t binding and OMB routinely exceeds it, sometimes by months. In 2013, it took over six months for OMB to review the proposed deeming regulations from FDA.
The grandfather date referenced in the letter is Feb. 15, 2007. It’s a date that was established by the Family Smoking Prevention and Tobacco Control Act in 2009, a law passed by Congress. Any product marketed prior to Feb. 15, 2007 will be largely exempt from FDA regulation. FDA has repeatedly said that it does not have the authority to change the date.
Numerous businesses would like to have this date changed, including the premium cigar industry, although none as much as the e-cigarette industry. Over the last eight years, e-cigarettes and vaping have evolved into a multi-billion dollar business with constant innovation. Most of the products offered today would not meet the Feb. 15, 2007 date meaning they would have to submit for FDA approval.
Cigars that don’t meet the date would be able to apply under the substantial equivalence provision, a cigar manufacturer would submit that their cigar(s) doesn’t pose any greater public health risk than already approved or grandfathered product. Because of the evolution of the e-cigarette and vaping technology, it’s likely that many products on the market today wouldn’t get to use the substantial equivalence provision and as such have to apply as a new product, something that would require exponentially more costly.
As such, lobbying to change the date has been fierce by both industries. In July, the House Appropriations Committee passed the FY 2016 Agriculture Appropriations Bill, in it was a provision that would require FDA to change the grandfather date to whenever the rule was enacted, otherwise the agency would risk losing funding.
Most of the senators on the letter have been public about their support for FDA regulations with Durbin and Blumenthal being perhaps the most noted.
In May, Blumenthal indicated that he would introduce legislation into the senate if FDA didn’t enact regulations by the end of summer. While he didn’t follow through on that promise, he was a co-sponsor to S.2100, which would raise the minimum age to purchase tobacco to 21. Seven of the nine co-sponsors to that bill are included on the letter.
(For more information about the FDA’s proposed regulation of premium cigars, visit halfwheel.com/fda)
The letter is as follows:
Dear Director Donovan:
We are writing, more than six years after Congress passed the Family Smoking Prevention and Tobacco Control Act giving the Food and Drug Administration direct authority to begin regulating all tobacco products, to urge the Office of Management and Budget’s Office of Information and Regulatory Affairs (OIRA) to complete its review of the FDA’s final tobacco deeming rule as soon as possible. We also strongly urge that the final rule gives FDA authority over all tobacco products, including e-cigarettes, and does not move the “grandfather date” for new products.
As you know, Executive Order 12866 limits to 90 days the period for OIRA review. Yesterday, an FDA spokesman stated that “[w]hile the office has 90 calendar days to review rules, the window could be extended to allow for further interagency discussions.” Finalizing this rule cannot wait until 2016. The proposed deeming rule was issued over eighteen months ago on April 25, 2014 and FDA, HHS, and OMB have had ample time to confer.
Every day of further delay is compromising the health of America’s youth. According to the Centers for Disease Control and Prevention (CDC) 2014 National Youth Tobacco Survey released in May, e-cigarette use among high school students tripled in the last year, from 4.5 percent in 2013 to 13.4 percent in 2014. In the six years since the passage of the Tobacco Control Act, tobacco and e-cigarette companies have had time to develop new, innovative products, many with candy and fruit flavors, to attract and ultimately addict America’s youth.
Due to the impact this rule will have on protecting public health, we urge OIRA to complete its review expeditiously so that FDA can issue the final rule as soon as possible. In Executive Order 13563, President Obama confirmed the need for a transparent and timely review process. Once the deeming rule is final, FDA will be able to regulate new tobacco products in important ways. These include imposing minimum age standards, limits on advertising, and health warnings on the products; requiring the registration of tobacco product manufacturers with FDA; and mandating FDA approval of some novel products.
We urge OMB to work quickly to finalize review of the final deeming rule, ensuring that the rule gives FDA authority over all tobacco products including e-cigarettes and cigars, explicitly bans the use of flavorings and marketing that appeals to children, and mandates child-proof packaging of e-liquids (liquid nicotine). We also implore that the final rule not move the “grandfather date” for new products (set at February 15, 2007). Altering this grandfather date would exempt a wide range of e-cigarettes and related products from any premarket review to determine whether they constitute threats to public health.
It is critical that the Administration take swift and immediate action to finalize the tobacco deeming rule in order to reduce tobacco’s harmful effects on public health, and especially the health of America’s youth.